Technical Reviewer QC Method Validation
Technical Reviewer – QC Method Validation
R51686
Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.
We are currently looking for an experienced Technical Reviewer to join our Centre of Excellence for QC Method Validation in Slough, UK.
The Technical Reviewer performs technical review of analytical assays including content (e.g. SoloVPE, A280), electrophoresis (e.g. SDS PAGE, CE SDS, icIEF), HPLC (e.g. GPC, IEX, RP including peptide map, sialic acid and oligosaccharides), potency (e.g. Activity and cell based ELISAs, Biocore) and impurities (e.g. qPCR, ligand leachate ELISAs and HCP ELISAs) for the purpose of assessing the analytical method performance of therapeutic proteins. The person will be mainly office based however will also be expected to complete activities such as system audit trail checks performed by other analysts in the laboratory. All work is expected to be carried out in a safe and compliant manner.
This is an office based position, working in collaboration with laboratory personnel and study director. As a Technical Reviewer you will be technically reviewing and signing off analytical data to a high quality standard and in compliance with Good Manufacturing Practice (GMP) principles in accordance with project timelines and internal delivery metrics.
Key responsibilities:
- Performs technical review of assays, data tables and study protocols/reports for evaluation, method validation and transfer studies against standard operating procedures, protocols and GMP principles
- Communicates with operators, study directors and managers to close-out technical review of assays
- Interprets data against study specifications, identifies atypical results / trends within data and supports and supports discussions for process improvements
- Provides support for the progress of quality records such as atypical / out of specification investigations and deviations, and department activities such as test method, retest extensions reviews
Key requirements:
- BSc in relevant scientific discipline (Biochemistry or Biotechnology) or relevant previous experience
- Demonstrated experience in a range of analytical methods such as HPLC, CE SDS and ELISA
- Working knowledge of reviewing data generated from analytical methods
- Experience working in a laboratory / contract research environment
- Knowledge of Good Manufacturing Practice (GMP) guidelines
- Good time management and organisational skills with ability to effectively plan and complete assigned tasks
- Excellent communication skills both written and verbal
- Proficient in the use of Microsoft Word and Excel
- Proactive nature and a desire to learn
Every day, Lonza’s products and services have a positive impact on millions of people. For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.
People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.
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